The HistoSonics System for Treatment of Primary Solid Renal Tumors Using Histotripsy (CAIN)
Primary Purpose
Renal Cancer, Tumor, Solid, Kidney Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HistoSonics System
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cancer
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥18 years of age
- Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments
- Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date
- Subject can tolerate general anesthesia
- Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date: • White Blood Cell (WBC) ≥3,000/mm3
- Absolute Neutrophil Count (ANC) ≥1,200/mm3
- Hemoglobin (Hgb) ≥9 g/dL
- Platelet count ≥100,000/mm3
- White Blood Count (WBC) ≤5 hpf via urinalysis
- Albumin ≤300 mg/g via urinalysis
- Calculated creatinine clearance ≤14 days prior to the planned index procedure date ≥45mL/min using the Cockcroft-Gault formula
International Normalized Ratio (INR) score of <1.5:
- If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR
- If only on aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed ≤14 days prior to the planned index procedure date; OR
- If not on anticoagulants, assessment must be performed ≤14 days prior to the planned index procedure date
- The tumor selected for histotripsy treatment must be ≤3cm in longest diameter
- Subject has an adequate acoustic window to visualize targeted tumor using the histotripsy system
- Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors the subject has
Exclusion Criteria:
- Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period
- Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date
- Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date
- Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date
- In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics System
- Subject is on dialysis
- Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or better from any adverse effects (except alopecia and neuropathy) related to previous anti-cancer therapy
- Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs
- Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit
- Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy)
- Subject has previous treatment with immunotherapies that has not been discontinued ≥40-days prior to the planned index procedure date and has not recovered from related toxicity (CTCAE grade 2 or better)
- Subject has a life expectancy less than six (< 6) months
- In the investigator's opinion, histotripsy is not a treatment option for the subject
- Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol
- Subjects' targeted tumor has/have had prior locoregional therapy (e.g., ablation, embolization, radiation)
- Subjects' tumor is not treatable by the System's working ranges (refer to User Manual)
- In the physician's opinion, the anticipated risk of intervention outweighs the potential benefits of the intervention
- Subject has acute renal failure
Subject has a genetic predisposition to kidney cancer such as:
- Von Hippel Lindau (VHL)
- Hereditary Papillary Renal Carcinoma (HPRC)
- Birt-Hogg-Dubé Syndrome (BHD)
- Tuberous Sclerosis Complex (TSC)
- Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)
- Reed's Syndrome
- Succinate Dehydrogenase B Deficiency (SDHB)
- BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma
- MITF predisposed Renal Cell Carcinoma
- The targeted tumor is not clearly visible with diagnostic ultrasound and either magnetic resonance imaging (MRI) or computerized tomography (CT)
- Targeted tumor with adequate margin does not overlap the renal pelvis, main renal vessel, ureter, or other vital structure
- Targeted tumor with adequate margin does not overlap a non-targeted tumor visible via imaging
- The treatment of the tumor will not allow for an adequate margin as determined by the investigator -
Sites / Locations
- Leeds Teaching Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Histotripsy
Arm Description
HistoSonics System: non-invasive destruction of kidney tissue using histotripsy
Outcomes
Primary Outcome Measures
Primary Effectiveness Endpoint
Technical success defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT).
Primary Safety Endpoint
Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05432232
Brief Title
The HistoSonics System for Treatment of Primary Solid Renal Tumors Using Histotripsy
Acronym
CAIN
Official Title
The HistoSonics System for Treatment of Primary Solid Renal Tumors Using Histotripsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HistoSonics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics System for the treatment of primary solid renal tumors
Detailed Description
This trial is a prospective, multi-center, single-arm pilot trial designed to evaluate the effectiveness and safety profile of the HistoSonics System in treating primary solid renal tumors. Following histotripsy treatment of the solid renal tumor, subjects will undergo imaging ≤36 hours post-index procedure to determine technical success. Additionally, subjects will be followed 180 days (6 months) post-index procedure, with evaluations at the 14-day, 30-day, 90-day, and 180-day time points to establish the efficacy and safety profile of the HistoSonics System.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer, Tumor, Solid, Kidney Cancer, Tumor, Tumor, Benign
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This trial is prospective, multi-center, single-arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Histotripsy
Arm Type
Experimental
Arm Description
HistoSonics System: non-invasive destruction of kidney tissue using histotripsy
Intervention Type
Device
Intervention Name(s)
HistoSonics System
Intervention Description
HistoSonics System: non-invasive destruction of kidney tissue using histotripsy, a non-thermal mechanical process of focused ultrasound.
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint
Description
Technical success defined as complete coverage of the tumor as determined ≤36 hours post-index procedure by magnetic resonance imaging (MRI) or computerized tomography (CT).
Time Frame
Up to 36 hours after the index procedure
Title
Primary Safety Endpoint
Description
Freedom from index procedure related major complications, defined by Clavien-Dindo Classification Grade 3 or higher up to 30 days after the last histotripsy procedure.
Time Frame
30 days Post-Index Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥18 years of age
Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments
Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date
Subject can tolerate general anesthesia
Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening
Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date:
White Blood Cell (WBC) ≥3,000/mm3
Absolute Neutrophil Count (ANC) ≥1,200/mm3
Hemoglobin (Hgb) ≥9 g/dL
Platelet count ≥100,000/mm3
White Blood Count (WBC) ≤5 hpf via urinalysis
Albumin ≤300 mg/g via urinalysis
Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date
International Normalized Ratio (INR) score of <1.5:
If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR
If only on aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed ≤14 days prior to the planned index procedure date; OR
If not on anticoagulants, assessment must be performed ≤14 days prior to the planned index procedure date
Biopsy is required to determine the type of tumor and must be performed ≥14 days prior to the planned index procedure date.
The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.
Subject has an adequate acoustic window to visualize targeted tumor using the histotripsy system.
Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors the subject has
Exclusion Criteria:
Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period.
Subject is enrolled and being actively treated in another investigational pharmaceutical or device trial ≤30 days prior to planned index procedure date.
Subject is undergoing active chemotherapy for any cancer ≤14 days prior to planned index procedure date.
Subject is undergoing active immunotherapy ≤40 days prior to planned index procedure date.
In the Investigator's opinion, the subject has co-morbid disease(s) or condition(s) that would cause undue risk and preclude safe use of the HistoSonics System.
Subject is on dialysis or being considered for dialysis.
Subject has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or better from any adverse effects (except alopecia and neuropathy) related to previous anti-cancer therapy.
Subject has an uncorrectable coagulopathy other than that induced by aspirin or non-steroidal anti-inflammatory drugs.
Subject has a planned cancer treatment (e.g., nephrectomy, chemotherapy, immunotherapy etc.) prior to completion of the 30-day follow-up visit.
Subject has had previous treatments with chemotherapy, radiotherapy, or both that have not been discontinued ≥14 days prior to the planned index procedure date and have not recovered (CTCAE grade 2 or better) from related toxicity (exclusive of alopecia and neuropathy).
Subject has previous treatment with immunotherapies that has not been discontinued ≥40-days prior to the planned index procedure date and has not recovered from related toxicity (CTCAE grade 2 or better).
Subject has a life expectancy less than one (< 1) year.
In the investigator's opinion, histotripsy is not a treatment option for the subject.
Subject has a concurrent condition that could jeopardize the safety of the subject or compliance with the protocol.
Subjects' targeted tumor has/have had prior locoregional therapy (e.g., ablation, embolization, radiation).
Subjects' tumor is not treatable by the System's working ranges (refer to User Manual).
In the physician's opinion, the anticipated risk of intervention outweighs the potential benefits of the intervention.
Subject has acute renal failure.
Subject has a genetic predisposition to kidney cancer such as:
Von Hippel Lindau (VHL)
Hereditary Papillary Renal Carcinoma (HPRC)
Birt-Hogg-Dubé Syndrome (BHD)
Tuberous Sclerosis Complex (TSC)
Hereditary Leiomyomata's Renal Cell Carcinoma (HLRCC)
Reed's Syndrome
Succinate Dehydrogenase B Deficiency (SDHB)
BRCA 1 associated protein -1 (BAP1) Renal Cell Carcinoma
MITF predisposed Renal Cell Carcinoma
Tumor is an angiomyolipoma.
Subject has a known sensitivity to contrast media and cannot be adequately pre-medicated.
The targeted tumor is not clearly visible with diagnostic ultrasound and either magnetic resonance imaging (MRI) or computerized tomography (CT).
Targeted tumor with adequate margin overlaps the renal pelvis, main renal vessel, ureter, or other vital structure.
Targeted tumor with adequate margin overlaps a non-targeted tumor visible via imaging.
The treatment of the tumor will not allow for an adequate margin as determined by the investigator.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Dickson
Phone
612-351-0361
Email
amber.dickson@histosonics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zoe Secord
Phone
612-351-0361
Email
zoe.secord@histosonics.com
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daffodil Pastor
Email
daffodil.pastor@nhs.net
First Name & Middle Initial & Last Name & Degree
Tze Wah, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The HistoSonics System for Treatment of Primary Solid Renal Tumors Using Histotripsy
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